Achieve Life Sciences Announces Key NDA Milestones For Cytisinicline; Co Submits 120-Day Update To FDA; Concludes ORCA-OL Safety Trial; DSMC Finds No Safety Concerns For Cytisinicline

Author: Benzinga Newsdesk | November 03, 2025 08:41am

Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced several milestones in its ORCA-OL long-term safety trial supporting the New Drug Application (NDA) review process of cytisinicline for smoking cessation.

• 120-Day Safety Update: The company has submitted the 120-day safety update to the U.S. Food and Drug Administration (FDA) as part of the NDA review for cytisinicline. This update provides the most current and comprehensive long-term safety data available and includes data on 411 participants with at least six months of cumulative cytisinicline exposure and 214 participants with at least one year of cumulative cytisinicline exposure as of the agreed upon data cutoff on June 4, 2025.
   
• ORCA-OL Trial Completion: Achieve reported that the last participant in the ORCA-OL long-term safety trial completed treatment in October 2025, marking 334 participants who finished one full year of cytisinicline treatment. This level of participation exceeds FDA's request for cumulative cytisinicline safety data of at least one year from 100 participants and at least six months from 300 participants before approval.
• Data Safety Monitoring Committee (DSMC): The company announced completion of the fourth and final scheduled safety review by the DSMC for the ORCA-OL trial. Adverse events were mostly mild in severity, and no serious adverse events were deemed to be treatment related. The DSMC found no concerns with respect to drug safety.

Posted In: ACHV